o Manage study documents such as study level, country level and site level
o Maintain study databases (CTMS, IWRS, EDC etc.)
o Support study team in e-TMF management activities
o Support study team in data review and support activities
o Upload, check, correct and maintain study documents for document review in the study eTMF regionally.
§ Send study documents for document review to eTMF archivist after release
§ Provide study documents for document review to the client as per study specific Investigator Package Plan
§ Perform tracking and data entry activities related to document review
§ Maintain and update document tracking information in CTMS and/or other tracking logs/systems
§ Perform administrative tasks required during the study (e.g. archiving, return files to client at end of the study)
o To complete required trainings according to required timelines.
§ To complete day-to-day tasks ensuring quality and productivity.
§ To maintain project and technical documentation in an appropriate manner.
§ To perform checks to ensure quality of work completed
§ To ensure timely escalation as needed.
§ To assist in the document management (including document template creation, collection, review, processing and tracking up to eTMF filing) for all documents in the scope of agreed processes/activities or within the scope of GSDM throughout the study duration
o To assist the study, start up teams with tasks required for site start up activities.
§ To manage and support assigned studies for upload as per set objectives
§ To follow up with study team on uploading queries
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